Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis

TORONTO, April 22, 2019 /CNW/ - Eli Lilly and Company announced today that Taltz^® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. These results provide clinical evidence to support a potential role for Taltz in the treatment of nr-axSpA patients.

Taltz met the primary endpoint at both week 16 and week 52, demonstrating a statistically significant improvement in the signs and symptoms of nr-axSpA, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo.

Taltz also met the major secondary endpoints at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation (SIJ) as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score.

In COAST-X, the safety profile of Taltz was consistent with previously reported Phase 3 studies of Taltz. No new safety signals were detected.

"Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients," said Atul Deodhar, M.D., professor of medicine, Oregon Health & Science University and clinical investigator for the COAST program. "The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population."

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the axial skeleton and is estimated to affect 4.5 million adults worldwide.^i,ii,iii AxSpA is recognized as a single disease entity, with a patient subset defined by the presence of radiographically defined structural damage of the sacroiliac joints (radiographic axSpA or ankylosing spondylitis [AS]) and a patient subset without clear structural damage radiographically (nr-axSpA).^iv These two patient subsets share a similar burden of disease and similar clinical features, such as spinal inflammation and chronic inflammatory back pain.^v,vi The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of Taltz across various population subsets of patients with axSpA. Results from COAST-V and COAST-W, which evaluated Taltz in AS, were reported in 2018.

"We're encouraged by the results of the COAST-X trial, which support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S. for people with non-radiographic axSpA," said Christi Shaw, president, Lilly Bio-Medicines. "The COAST-X data add to the growing body of evidence from our COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum."

Lilly plans to submit detailed data from COAST-X for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on these positive data, Lilly plans to submit to regulatory authorities in 2019 for approval for nr-axSpA.

Lilly's application for radiographic axSpA is currently under review with the U.S. Food and Drug Administration (FDA) and regulatory action is expected later this year.

About the SPIRIT-H2H Study
COAST-X is a multicentre, randomized, double-blind, placebo-controlled 52-week study evaluating the efficacy and safety of Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. Patients were required to have an established diagnosis of nr-axSpA and active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ?4 and total back pain ?4 at screening and baseline, and were required to have objective signs of inflammation by presence of sacroiliitis on MRI or presence of elevated CRP.

About the Taltz Program in axSpA
The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of ixekizumab across various population subsets of patients with axSpA. The COAST program includes three registration studies each of one year duration: COAST-V in patients with Ankylosing Spondylitis (AS)/radiographic axSpA who are bDMARD-naïve; COAST-W in patients with AS/radiographic axSpA who previously had an inadequate response or were intolerant to TNF inhibitors; and COAST-X in patients with non-radiographic axSpA who are bDMARD-naïve. Patients may enroll into a long-term extension study after completion of any of the registration studies to receive ixekizumab treatment for up to an additional two years (COAST-Y).

About Taltz^®
Taltz^® is an interleukin (IL) 17A inhibitor containing the active substance ixekizumab. This monoclonal antibody (protein) recognizes and binds specifically to certain proteins.^vii IL-17A is a protein that is found to be present in high levels in inflammatory diseases such as plaque psoriasis and psoriatic arthritis.^vii Taltz neutralizes IL-17A, thus reducing the signs and symptoms of psoriatic arthritis and plaque psoriasis, such as itching, pain, and scaling.^vii The full Canadian Product Monograph for Taltz (ixekizumab) is available here. The approval of Taltz for PsA is based on data from the double blind, multi-centre, randomized, placebo-controlled SPIRIT-P1 and SPIRIT-P2 clinical trials, which assessed the safety and efficacy of Taltz compared to placebo in 780 adults with active PsA.^vii

• SPIRIT-P1 evaluated the safety and efficacy of ixekizumab compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug.
• SPIRIT-P2 evaluated the safety and efficacy of ixekizumab compared to placebo in tumour necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors or were intolerant to a TNF inhibitor.
• In both studies, the primary efficacy endpoint was the proportion of patients who, at 24 weeks, had achieved ACR20 response, which represents at least a 20 per cent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR).
• Results from both studies demonstrated that more than half of patients treated with Taltz reached ACR20 by Week 24 and showed significant improvement in joint symptoms, compared to placebo:
• SPIRIT-P1: 58 per cent of patients treated with Taltz reached ACR20 compared to 30 per cent on placebo.
• SPIRIT-P2: 53 per cent of patients treated with Taltz reached ACR20 compared to 20 per cent on placebo.
• Additionally, both studies evaluated improvement in psoriasis plaques at 12 weeks, as measured by improvement in the Psoriasis Area Severity Index (PASI) of at least a 75 per cent. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaling of skin lesions, weighted by the body surface area of involved skin.
• The following proportion of patients achieved PASI 75 responses:
• SPIRIT-P1: 75.3 per cent of patients treated with Taltz compared to placebo (7.5 per cent). In SPIRIT-P1, patients experienced improvement in itch severity, when compared to placebo at Week 12.
• SPIRIT-2: 57.4 per cent of patients treated with Taltz compared to placebo (10.4 per cent).^vii

About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across its immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.

About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

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